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12 active trials for Heart Transplantation

Cost-utility Analysis of the AlloMap® Test

Transplant rejection is one of the most important complications of heart transplantation and requires a specific monitoring, including regular and invasive endomyocardial biopsies. The average hospital cost of a biopsy has been estimated at 3 297 dollars in United States. In France, the reimbursement rates by the Health Insurance for the corresponding stays vary from 682 to 25 865 euros, according to the finding of a rejection and its severity. AlloMap® is a non-invasive blood test that can identify patients with low probability of moderate to severe acute cell transplant rejection. The non-inferiority of the use of the AlloMap® test has been demonstrated in comparison of the usual care in terms of diagnosis of acute cellular rejection in a randomized study conducted in the United States. Following this study, the ISHLT (International Society of Heart and Lung Transplantation) made recommendations advocating its use for these patients between 6 months and 5 years after heart transplantation. This new test could be an alternative to systematic biopsies usually performed to patients whose allograft function is stable, but it is very expensive since the analysis of a blood sample cost 2 000 euros pre-tax in France. This cost has to be compared with the current patient care. By replacing biopsies performed systematically, the test should reduce the costs of full and day hospitalizations for the realization of biopsies but also the costs associated with their possible complications. In addition, it can be expected that its use provides a benefit to the patient in terms of quality of life. Indeed, the achievement of a biopsy may cause significant stress and anxiety for the patient, due to discomfort, pain and potential complications that may be severe. To this day, no medico-economic assessment has been conducted to prove the interest of the use of AlloMap® compared to systematic realization of endomyocardial biopsies. The purpose of the CUPIDON study is to assess the effectiveness of the use of the AlloMap® test for monitoring heart transplant patients in the context of usual care and in accordance with international recommendations. AlloMap® will be used and compared to the current surveillance strategy by endomyocardial biopsies from 6 months to 36 months after heart transplantation. The investigators hypothesize that the use of this test for the diagnosis of acute cellular transplant rejection would avoid the costs of a large number of biopsies, while increasing the quality of life of patients related to their health.

Start: April 2016
Advanced Cardiac Imaging in Cardiac Allograft Vasculopathy

Cardiac allograft vasculopathy (CAV) is a process of both immune and non-immune mediated thickening of the heart arteries of transplanted hearts. CAV limits the long term survival of heart transplant patients and is one of the common causes of death in the late post transplant period. Current methods of detecting CAV rest with invasive cardiac catheterization which carry repeated risks, as this test needs to be performed periodically through the life of a heart transplant patient. Traditional methods of coronary angiography identify CAV late in its course and is a crude method of evaluating coronary anatomy in heart transplant patients. Intravascular ultrasound is an additive tool that is able to detect early CAV before it becomes angiographically apparent, but still requires invasive cardiac catheterization to perform. However, it also limits assessment to the major epicardial arteries and does not give any information regarding the smaller branch vessels and cardiac microvasculature. Advances in cardiac CT and cardiac MRI hold potential to evaluate for CAV non-invasively. In addition, perfusion techniques may provide additional functional information regarding the status of the microvascular. In this pilot study, we aim to demonstrate the feasibility of cardiac CT and cardiac MRI with and without perfusion protocols, in patients post-heart transplant and to describe and compare CT and MRI findings in patients with established CAV versus those with no CAV, as diagnosed by standard invasive methods.

Start: September 2014